RGA 6410 — Fundamentals of CMC Regulations and Methods
4 semester hoursGraduateLecture
Discusses components of the Common Technical Document Module 3 and describes how regulatory affairs professionals support compliance with CMC regulation. Offers students an opportunity to design and evaluate core elements of an effective CMC compliance strategy, ensuring alignment with ICH guidelines, FDA Guidances, pharmacopeia, and 21 CFR. Chemistry, manufacturing, and controls (CMC) regulatory affairs professionals must use technical, analytical expertise and problem-solving abilities to ensure only quality product is distributed to patients.